Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex.

Phase 1

• Conditions: Tuberous sclerosis complex

• Registration Number: JPRN-UMIN000012420
• Lead Sponsor: Department of Dermatology Graduate School of Medicine, Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-27
• Study Completion: 2014-07-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who cannot carry out this treatment plan or follow-up assessment. 2)Patients who have serious skin lesions such as erosions or ulcers. 3)Patients who have allergy to macrolide antibiotics. 4)Patients who received sirolimus, everolimus or temsirolimus administration within twelve months prior to the study entry. 5)Patients who received topical treatment of tacrolimus, vitamin D or steroid within three months prior to the study entry. 6)Patients who received laser therapy or surgical therapy within six months prior to the study entry. 7)Patients during pregnancy or lactation. 8)Patients who were judged unsuitable for this clinical trial by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified